UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014143
Receipt number R000016359
Scientific Title Study of the surgery without systematic lymphadenectomy for metastatic negative patients using sentinel lymph node biopsy in cervical cancer patients
Date of disclosure of the study information 2014/06/02
Last modified on 2018/01/05 10:06:42

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Basic information

Public title

Study of the surgery without systematic lymphadenectomy for metastatic negative patients using sentinel lymph node biopsy in cervical cancer patients

Acronym

Study of the surgery without systematic lymphadenectomy using sentinel lymph node biopsy

Scientific Title

Study of the surgery without systematic lymphadenectomy for metastatic negative patients using sentinel lymph node biopsy in cervical cancer patients

Scientific Title:Acronym

Study of the surgery without systematic lymphadenectomy using sentinel lymph node biopsy

Region

Japan


Condition

Condition

Uterine cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Utility of the surgery without systematic lymphadenectomy in cervical cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of lymphedema

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We perform the surgery without systematic lymphadenectomy using sentinel lymph node biopsy in cervical cancer patients

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >

Gender

Female

Key inclusion criteria

Uterine cervical cancer Stage 1-2A(FIGO criteria)
Squamous cell carcinoma

Key exclusion criteria

bad general condition
(performance status 2-4)

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Niikura

Organization

Tohoku University Hospital

Division name

gynecology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7254

Email

niikura@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Asami Toki

Organization

Tohoku University Hospital

Division name

gynecology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7254

Homepage URL


Email

asa_tannpopo_pon@yahoo.co.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 02 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2014 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 06 Month 02 Day

Last modified on

2018 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016359


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name